Bioethics and Medical Ethics Commons^™

Hope And Optimism In Pediatric Deep Brain Stimulation: Key Stakeholder Perspectives, Natalie Dorfman, Lilly Snellman, Ynez Kerley, Kristin Kostick-Quenet, Gabriel Lazaro-Munoz, Eric A Storch, Jennifer Blumenthal-Barby

Center for Medical Ethics and Health Policy Staff Publications

Introduction: Deep brain stimulation (DBS) is utilized to treat pediatric refractory dystonia and its use in pediatric patients is expected to grow. One important question concerns the impact of hope and unrealistic optimism on decision-making, especially in "last resort" intervention scenarios such as DBS for refractory conditions.

Objective: This study examined stakeholder experiences and perspectives on hope and unrealistic optimism in the context of decision-making about DBS for childhood dystonia and provides insights for clinicians seeking to implement effective communication strategies.

Materials and methods: Semi-structured interviews with clinicians (n = 29) and caregivers (n = 44) were conducted, …

Ethics Education For Healthcare Professionals In The Era Of Chatgpt And Other Large Language Models: Do We Still Need It?, Vasiliki Rahimzadeh, Kristin Kostick-Quenet, Jennifer Blumenthal Barby, Amy L Mcguire

Center for Medical Ethics and Health Policy Staff Publications

In this paper, we contend with whether we still need traditional ethics education as part of healthcare professional training given the abilities of chatGPT (generative pre-trained transformer) and other large language models (LLM). We reflect on common programmatic goals to assess the current strengths and limitations of LLMs in helping to build ethics competencies among future clinicians. Through an actual case analysis, we highlight areas in which chatGPT and other LLMs are conducive to common bioethics education goals. We also comment on where such technologies remain an imperfect substitute for human-led ethics teaching and learning. Finally, we conclude that the …

Clinician Perspectives On Levels Of Evidence And Oversight For Deep Brain Stimulation For Treatment-Resistant Childhood Ocd, Michelle T Pham, Tiffany A Campbell, Natalie Dorfman, Laura Torgerson, Kristin Kostick-Quenet, Jennifer Blumenthal-Barby, Eric A Storch, Gabriel Lázaro-Muñoz

Center for Medical Ethics and Health Policy Staff Publications

Approximately 10-20% of children with obsessive-compulsive disorder (OCD) have treatment-resistant presentations, and there is likely interest in developing interventions for this patient group, which may include deep brain stimulation (DBS). The World Society for Stereotactic and Functional Neurosurgery has argued that at least two successful randomized controlled trials should be available before DBS treatment for a psychiatric disorder is considered "established." The FDA approved DBS for adults with treatment-resistant OCD under a humanitarian device exemption (HDE) in 2009, which requires that a device be used to manage or treat a condition impacting 8,000 or fewer patients annually in the United …

Professional Virtue Of Civility And The Responsibilities Of Medical Educators And Academic Leaders, Laurence B Mccullough, John Coverdale, Frank A Chervenak

Center for Medical Ethics and Health Policy Staff Publications

Incivility among physicians, between physicians and learners, and between physicians and nurses or other healthcare professionals has become commonplace. If allowed to continue unchecked by academic leaders and medical educators, incivility can cause personal psychological injury and seriously damage organisational culture. As such, incivility is a potent threat to professionalism. This paper uniquely draws on the history of professional ethics in medicine to provide a historically based, philosophical account of the professional virtue of civility. We use a two-step method of ethical reasoning, namely ethical analysis informed by pertinent prior work, followed by identifying the implications of clearly articulated ethical …

Researching The Future: Scenarios To Explore The Future Of Human Genome Editing, Cynthia Selin, Lauren Lambert, Stephanie Morain, John P Nelson, Dorit Barlevy, Mahmud Farooque, Haley Manley, Christopher T Scott

Center for Medical Ethics and Health Policy Staff Publications

Background: Forward-looking, democratically oriented governance is needed to ensure that human genome editing serves rather than undercuts public values. Scientific, policy, and ethics communities have recognized this necessity but have demonstrated limited understanding of how to fulfill it. The field of bioethics has long attempted to grapple with the unintended consequences of emerging technologies, but too often such foresight has lacked adequate scientific grounding, overemphasized regulation to the exclusion of examining underlying values, and failed to adequately engage the public.

Methods: This research investigates the application of scenario planning, a tool developed in the high-stakes, uncertainty-ridden world of corporate strategy, …

A Pre-Medical Student’S Reconciliation Of Feminist Narratives Regarding Women’S Health: A Consideration Of Perspectives On Childbirth In The U.S., Laura Clayton

sprinkle: an undergraduate journal of feminist and queer studies

Many feminists argue that one major negative aspect of reproductive healthcare in the U.S. is the common over-medicalization of women during childbirth, including potentially unnecessary procedures such as cesarean-section and episiotomy. As a solution, they advocate for increased involvement of midwives in childbirth practices, as midwives allow women to give birth at home with minimal medical intervention. This paper analyzes the benefits of midwifery as well as the current increased risk associated with homebirth in the U.S. Additionally, it questions the damaging stigma associated with assumptions of cesarean-section as a suboptimal outcome. A false dichotomy has developed in our culture …

Poverty And Commercial Surrogacy In India: An Intersectional Analytical Approach, Sheela Suryanarayanan

Dignity: A Journal of Analysis of Exploitation and Violence

The destination and source countries for commercial surrogacy match world patterns of inequality. India, Nepal, Thailand, Mexico, and Cambodia banned commercial surrogacy, moving the market to other less-developed countries in South Africa and South America. India had a commercial surrogacy boom until exploitative factors led to the passage of the Surrogacy (Regulation) Bill in 2019, which banned the practice. This paper examines surrogacy's monetary, health, and emotional effects on 45 surrogate mothers in Gujarat State, India. The study revealed that a majority (63%) of the very poor women remained very poor post-surgery. Surrogate mothers in poor households had to do …

Cell-Based Noninvasive Prenatal Testing (Cbnipt)-A Review On The Current Developments And Future Prospects, Mohamad Ali Maktabi, Liesbeth Vossaert, Ignatia B Van Den Veyver

Center for Medical Ethics and Health Policy Staff Publications

Considering the diagnostic limitations of cfDNA-based noninvasive prenatal testing (NIPT), scientists have long been interested in isolating and analyzing rare intact fetal and trophoblast cells from maternal blood or endocervical samples to diagnose fetal genetic conditions. These cells may be scarce and difficult to isolate, but they are a direct source of pure fetal genetic material. In this review, we summarize the history of cell-based NIPT, present an updated review on its current developments, evaluate its genetic diagnostic potential, and discuss its future prospects for clinical use.

Apoe Risk Disclosure: A Review Of Positive And Negative Outcome, Stacey Rowcliffe

Dissertations

Two of this century’s most significant healthcare challenges are Alzheimer’s disease and mild cognitive impairment, with 40 million people suffering from the diseases. In fact, a conservative estimate projects that both conditions will double every 20 years until 2050. Alzheimer’s disease involves memory impairment, disorientation, confusion, and various problematic behaviors. Presently, no prevention method or cure has been discovered for Alzheimer’s. Mild cognitive impairment typically includes problems with memory, language, thinking, and judgment beyond those typical of one’s age. Usually, these symptoms do not interfere with daily activities but do not improve and have been linked with a risk of …

Closing The Gap For Children With Ocd: A Staged-Care Model Of Cognitive Behavioural Therapy With Exposure And Response Prevention, Lara J Farrell, Allison M Waters, Eric A Storch, Gabrielle Simcock, Iain E Perkes, Jessica R Grisham, Katelyn M Dyason, Thomas H Ollendick

Center for Medical Ethics and Health Policy Staff Publications

Childhood obsessive-compulsive disorder (OCD) is among the most prevalent and disabling mental health conditions affecting children and adolescents. Although the distress and burden associated with childhood OCD are well documented and empirically supported treatments are available, there remains an unacceptable "treatment gap" and "quality gap" in the provision of services for youth suffering from OCD. The treatment gap represents the large number of children who never receive mental health services for OCD, while the quality gap refers to the children and young people who do access services, but do not receive evidence-based, cognitive behavioural therapy with exposure and response prevention …

Childhood Exposure To Parental Threatening Behaviors And Anxiety In Emerging Adulthood: Indirect Effects Of Perceived Stress, Erika S Trent, Andres G Viana, Elizabeth M Raines, Haley E Conroy Busch, Karina Silva, Eric A Storch, Michael J Zvolensky

Center for Medical Ethics and Health Policy Staff Publications

Background: Although childhood exposure to parental threatening behaviors is associated with elevated anxiety in emerging adulthood, the underlying mechanisms remain unexplored. Perceived stress-a subjective experience comprised of feelings of helplessness (being unable to cope or exert control) and poor self-efficacy (confidence in one's ability to manage stressors)-is one candidate mechanism. The present investigation examined the underlying role of perceived stress in the association between childhood exposure to parental threatening behaviors and anxiety symptom severity in a sample of emerging adults.

Methods: Participants (N = 855; Mage = 18.75 years, SD = 1.05, range 18-24; 70.8% female) were recruited from a …

Common Rituals In Obsessive-Compulsive Disorder And Implications For Treatment: A Mixed-Methods Study, Caitlin M Pinciotti, Nyssa Z Bulkes, Brenda E Bailey, Eric A Storch, Jonathan S Abramowitz, Leonardo F Fontenelle, Bradley C Riemann

Center for Medical Ethics and Health Policy Staff Publications

Obsessive-compulsive disorder (OCD) is characterized by engagement in rituals that serve to obtain certainty and prevent feared outcomes. Exposure and response prevention is most effective when rituals are resisted, yet existing self-report measures of OCD limit identification of the full range of possible rituals, and little is known about how rituals might cluster together and predict worsened severity and poorer treatment outcomes. In a retrospective sample of 641 adult patients who received intensive OCD treatment, the present study used a mixed-methods approach to (a) identify and validate treatment provider-identified rituals using the Yale-Brown Obsessive-Compulsive Scale, (b) identify clustering patterns of …

Integrating Social Determinants Of Health Into Ethical Digital Simulations, Kristin Kostick-Quenet, Vasiliki Rahimzadeh, Sharmila Anandasabapathy, Meghan Hurley, Anika Sonig, Amy Mcguire

Center for Medical Ethics and Health Policy Staff Publications

No abstract provided.

International Society For Cell & Gene Therapy Position Paper: Key Considerations To Support Evidence-Based Cell And Gene Therapies And Oppose Marketing Of Unproven Products, Laertis Ikonomou, Natividad Cuende, Miguel Forte, Bambi J Grilley, Aaron D Levine, Megan Munsie, John E J Rasko, Leigh Turner, Hamid R Bidkhori, Rachele Ciccocioppo, Felix Grignon, Alok Srivastava, Daniel J Weiss, Patricia Zettler, Bruce L Levine

Center for Medical Ethics and Health Policy Staff Publications

The field of regenerative medicine, including cellular immunotherapies, is on a remarkable growth trajectory. Dozens of cell-, tissue- and gene-based products have received marketing authorization worldwide while hundreds-to-thousands are either in preclinical development or under clinical investigation in phased clinical trials. However, the promise of regenerative therapies has also given rise to a global industry of direct-to-consumer offerings of prematurely commercialized cell and cell-based products with unknown safety and efficacy profiles. Since its inception, the International Society for Cell & Gene Therapy Committee on the Ethics of Cell and Gene Therapy has opposed the premature commercialization of unproven cell- and …

High Foxa1 Levels Induce Er Transcriptional Reprogramming, A Pro-Metastatic Secretome, And Metastasis In Endocrine-Resistant Breast Cancer, Xiaoyong Fu, Resel Pereira, Chia-Chia Liu, Carmine De Angelis, Martin J Shea, Sarmistha Nanda, Lanfang Qin, Tamika Mitchell, Maria L Cataldo, Jamunarani Veeraraghavan, Vidyalakshmi Sethunath, Mario Giuliano, Carolina Gutierrez, Balázs Győrffy, Meghana V Trivedi, Ofir Cohen, Nikhil Wagle, Agostina Nardone, Rinath Jeselsohn, Mothaffar F Rimawi, C Kent Osborne, Rachel Schiff

Center for Medical Ethics and Health Policy Staff Publications

Aberrant activation of the forkhead protein FOXA1 is observed in advanced hormone-related cancers. However, the key mediators of high FOXA1 signaling remain elusive. We demonstrate that ectopic high FOXA1 (H-FOXA1) expression promotes estrogen receptor-positive (ER+) breast cancer (BC) metastasis in a xenograft mouse model. Mechanistically, H-FOXA1 reprograms ER-chromatin binding to elicit a core gene signature (CGS) enriched in ER+ endocrine-resistant (EndoR) cells. We identify Secretome14, a CGS subset encoding ER-dependent cancer secretory proteins, as a strong predictor for poor outcomes of ER+ BC. It is elevated in ER+ metastases vs. primary tumors, irrespective of ESR1 mutations. Genomic ER binding near …

Intraoperative Predictors Of In-Hospital Mortality After Open Repair Of Ruptured Abdominal Aortic Aneurysms, Nicola Troisi, Giulia Bertagna, Athanasios Saratzis, Simone Guadagni, Fabrizio Minichilli, Daniele Adami, Mauro Ferrari, Raffaella Berchiolli

Center for Medical Ethics and Health Policy Staff Publications

Background: Several models and scores have been released to predict early mortality in patients undergoing surgery for a ruptured abdominal aortic aneurysm (rAAA). These scores included above all preoperative factors and they could be useful to deny surgical repair. The aim of the study was to evaluate intraoperative predictors of in-hospital mortality in patients undergoing open surgical repair (OSR) for a rAAA.

Methods: Between January 2007 and December 2020, 265 patients were admitted at our tertiary referral hospital for a rAAA. Two-hundred-twenty-two patients underwent OSR. Intra-operative factors were analyzed by means of univariate analysis (step 1). Associations of procedure variables …

Polymorphisms In The Nonhomologous End-Joining Dna Repair Pathway Are Associated With Hpv Integration In Cervical Dysplasia, Jennifer M Geris, E Susan Amirian, Deborah A Marquez-Do, Martial Guillaud, Laura M Dillon, Michele Follen, Michael E Scheurer

Center for Medical Ethics and Health Policy Staff Publications

Previous evidence indicates that HPV integration status may be associated with cervical cancer development and progression. However, host genetic variation within genes that may play important roles in the viral integration process is understudied. The aim of this study was to examine the association between HPV16 and HPV18 viral integration status and single nucleotide polymorphisms (SNPs) in non-homologous end-joining (NHEJ) DNA repair pathway genes on cervical dysplasia. Women enrolled in two large trials of optical technologies for cervical cancer detection and positive for HPV16 or HPV18 were selected for HPV integration analysis and genotyping. Associations between SNPs and cytology (normal, …

The Dilemma Of Socrates’ Position: Interview Methods And Feminist Empirical Bioethics, Michiel De Proost

The Qualitative Report

There is a growing body of bioethics research that addresses the importance of adapting empirical, predominantly qualitative, methods to generate debate on ethical arguments. However, there is an absence of illustrative work examining how this could be realised from a feminist perspective. This article, seeking to address the research gap, examines interview methods through a reflexive lens. Drawing on the doctoral research I conducted through interviews with women who were interested in social egg freezing (i.e., healthy women freezing their eggs in anticipation of future infertility), I describe how I encountered a dilemma because of my gendered positionality and the …

Does Using Sofa Score For Ventilator Triage Among Covid 19 Patients Result In Suboptimal Allocation Of Medical Ventilators For The Bipoc Population?, Alexandrea Mp Masocco, Elisabeth Michel, Ebbin Dotson

Journal of Health Disparities Research and Practice

Introduction: Since the COVID-19 pandemic in the United States, Black, and Latinx populations have been disproportionately affected by the COVID-19 pandemic. It can be inferred with high confidence that those most vulnerable are the least likely to receive essential care. Kidney transplant allocation and COVID-19 triage protocols share commonalities in that both protocols involve using multivariate scored criteria with objective and subjective inputs. As such, the similar conclusion in outcomes is concerning. It is worth questioning whether the racial inequalities demonstrated in the COVID-19 pandemic related to access to life-saving ventilators were associated with triage protocols.

Methodology: Using an exploratory …

State Oversight Of Polypharmacy And Psychotropic Medication Use Among Individuals With Intellectual And Developmental Disabilities: A Three State Case Study, James Houseworth, Kami L. Gallus, Tiffany Greene, Steven R. Erickson, Jennifer Lynn Jones, Laura Vegas

Developmental Disabilities Network Journal

Adults with intellectual and developmental disabilities (IDD) are prescribed more medications than the general population, placing them at significantly higher risk for issues due to taking multiple medications (polypharmacy). There are currently no clear national standards for the administration of medications given this risk. The following policy analysis explores state policies related to prescription medication oversight. This analysis pays particular attention to the use of medications that alter one’s mental state (psychotropics) among people with IDD who receive home and community-based services (HCBS) in the United States. The article outlines current efforts implemented to reduce medication-related risks for people with …

Actionability Of Unanticipated Monogenic Disease Risks In Newborn Genomic Screening: Findings From The Babyseq Project, Robert C Green, Nidhi Shah, Casie A Genetti, Timothy Yu, Bethany Zettler, Melissa K Uveges, Ozge Ceyhan-Birsoy, Matthew S Lebo, Stacey Pereira, Pankaj B Agrawal, Richard B Parad, Amy L Mcguire, Kurt D Christensen, Talia S Schwartz, Heidi L Rehm, Ingrid A Holm, Alan H Beggs

Center for Medical Ethics and Health Policy Staff Publications

Newborn genomic sequencing (NBSeq) to screen for medically important genetic information is of considerable interest but data characterizing the actionability of such findings, and the downstream medical efforts in response to discovery of unanticipated genetic risk variants, are lacking. From a clinical trial of comprehensive exome sequencing in 127 apparently healthy infants and 32 infants in intensive care, we previously identified 17 infants (10.7%) with unanticipated monogenic disease risks (uMDRs). In this analysis, we assessed actionability for each of these uMDRs with a modified ClinGen actionability semiquantitative metric (CASQM) and created radar plots representing degrees of penetrance of the condition, …

Tissue Mass Spectrometry: How Solid Is Our Future?, Daisy Unsihuay, William S Phipps, Amanda G Paulovich, Jessica R Chapman, Axel Ducret, Livia S Eberlin, Jeffrey M Spraggins, Richard J A Goodwin

Center for Medical Ethics and Health Policy Staff Publications

No abstract provided.

Physician-Investigator, Research Coordinator, And Patient Perspectives On Dual-Role Consent In Oncology: A Qualitative Study, Stephanie R Morain, Dorit Barlevy, Steven Joffe, Emily A Largent

Center for Medical Ethics and Health Policy Staff Publications

Importance: Classic statements of research ethics generally advise against dual-role consent in which physician-investigators seek consent for research participation from patients with whom they have preexisting treatment relationships. Yet dual-role consent is common in clinical oncology research, as studies are often conducted in close relationship with clinical care.

Objective: To explore key stakeholders' perspectives on dual-role consent in clinical oncology trials.

Design, setting, and participants: This qualitative study with 43 participants was conducted at a National Cancer Institute-designated comprehensive cancer center from 2018 to 2022. Semistructured qualitative interviews of physician-investigators, research coordinators, and patients were performed. Respondents were recruited from …

Cognitive Behavioral Therapy For Children And Adolescents With Anxiety Disorders, Jordan T Stiede, Erika S Trent, Andres G Viana, Andrew G Guzick, Eric A Storch, Jonathan Hershfield

Center for Medical Ethics and Health Policy Staff Publications

Anxiety disorders are the most common class of psychiatric conditions among children and adolescents. The cognitive behavioral model of childhood anxiety has a strong theoretic and empirical foundation that provides the basis for effective treatment. Cognitive behavioral therapy (CBT), with an emphasis on exposure therapy, is the gold standard treatment for childhood anxiety disorders, with strong empirical support. A case vignette demonstrating CBT for childhood anxiety disorders in practice, as well as recommendations for clinicians, are also provided.

Mindfulness And Cognitive Emotion Regulation In Pediatric Misophonia, Samuel D Spencer, Andrew G Guzick, Matti Cervin, Eric A Storch

Center for Medical Ethics and Health Policy Staff Publications

Misophonia is characterized by decreased tolerance of ordinary human-generated trigger sounds and associated visual stimuli (e.g., chewing, sniffing, lip smacking), coupled with intense affective reactions. The disorder often begins during childhood or adolescence and is associated with impairment and distress in numerous life domains. Research has begun to examine the underlying psychological mechanisms of misophonia in adults, but studies in youth are limited. Trait mindfulness (i.e., nonjudgmental and nonavoidant present-moment awareness) and cognitive emotion regulation (i.e., cognitive processing, or responding to, emotionally arousing situations) are two proposed mechanisms that may underpin pediatric misophonia and associated functional impairment. In the present …

Child And Adolescent Psychiatrists’ Use, Attitudes, And Understanding Of Genetic Testing And Pharmacogenetics In Clinical Practice, Takahiro Soda, Amanda R Merner, Brent J Small, Laura N Torgerson, Katrina Muñoz, Jehannine Austin, Eric A Storch, Stacey Pereira, Gabriel Lázaro-Muñoz

Center for Medical Ethics and Health Policy Staff Publications

The purpose of this study was to report current practices and attitudes of child and adolescent psychiatrists (CAP) regarding diagnostic genetic and pharmacogenetic (PGx) testing. We surveyed 958 US-based practicing CAP. 54.9% of respondents indicated that they had ordered/referred for a genetic test in the past 12 months. 87% of respondents agreed that it is their role to discuss genetic information regarding psychiatric conditions with their patients; however, 45% rated their knowledge of genetic testing practice guidelines as poor/very poor. The most ordered test was PGx (32.2%), followed by chromosomal microarray (23.0%). 73.4% reported that PGx is at least slightly …

Call For Moral Recognition As Part Of Paediatric Assent, Jared Smith, Jennifer Blumenthal-Barby

Center for Medical Ethics and Health Policy Staff Publications

No abstract provided.

Withdrawing Extra Corporeal Membrane Oxygenation (Ecmo) Against A Family’S Wishes: Three Permissible Scenarios, Trevor M Bibler, Asma Zainab

Center for Medical Ethics and Health Policy Staff Publications

The ethical permissibility of unilaterally withdrawing life-sustaining technologies has been a perennial topic in transplant and critical care medicine, often focusing on CPR and mechanical ventilation. The permissibility of unilateral withdrawal of extracorporeal membrane oxygenation (ECMO) has been discussed sparingly. When addressed, authors have appealed to professional authority rather than substantive ethical analysis. In this Perspective, we argue that there are at least three (3) scenarios wherein healthcare teams would be justified in unilaterally withdrawing ECMO, despite the objections of the patient's legal representative. The ethical considerations that provide the groundwork for these scenarios are, primarily: equity, integrity, and the …

Ethical, Legal, And Social Implications Of Genomics Research: Implications For Building A More Racially Diverse Bioethics Workforce, Faith E Fletcher

Center for Medical Ethics and Health Policy Staff Publications

No abstract provided.

Child And Adolescent Psychiatrists’ Use, Attitudes, And Understanding Of Genetic Testing And Pharmacogenetics In Clinical Practice, Takahiro Soda, Amanda R Merner, Brent J Small, Laura N Torgerson, Katrina Muñoz, Jehannine Austin, Eric A Storch, Stacey Pereira, Gabriel Lázaro-Muñoz

Center for Medical Ethics and Health Policy Staff Publications

The purpose of this study was to report current practices and attitudes of child and adolescent psychiatrists (CAP) regarding diagnostic genetic and pharmacogenetic (PGx) testing. We surveyed 958 US-based practicing CAP. 54.9% of respondents indicated that they had ordered/referred for a genetic test in the past 12 months. 87% of respondents agreed that it is their role to discuss genetic information regarding psychiatric conditions with their patients; however, 45% rated their knowledge of genetic testing practice guidelines as poor/very poor. The most ordered test was PGx (32.2%), followed by chromosomal microarray (23.0%). 73.4% reported that PGx is at least slightly …